Dietary aflatoxins exposure, environmental enteropathy, and their relation with childhood stunting.

Childhood stunting is a global phenomenon affecting more than 149 million children under the age of 5 worldwide. Exposure to aflatoxins (AFs) in utero, during breastfeeding, and consumption of contaminated food affect the gut microbiome, resulting in intestinal dysfunction and potentially contributing to stunting. This review explores the potential relationship between AF exposure, environmental enteropathy and childhood stunting. AFs bind to DNA, disrupt protein synthesis and elicit environmental enteropathy (EE). An EE alters the structure of intestinal epithelial cells, impairs nutrient uptake and leads to malabsorption. This article proposes possible intervention strategies for researchers and policymakers to reduce AF exposure, EE and childhood stunting, such as exposure reduction, the implementation of good agricultural practices, dietary diversification and improving environmental water sanitation and hygiene.

Neonatal mortality risk of vulnerable newborns by fine stratum of gestational age and birthweight for 230 679 live births in nine low- and middle-income countries, 2000-2017.

OBJECTIVE: To describe the mortality risks by fine strata of gestational age and birthweight among 230 679 live births in nine low- and middle-income countries (LMICs) from 2000 to 2017. DESIGN: Descriptive multi-country secondary data analysis. SETTING: Nine LMICs in sub-Saharan Africa, Southern and Eastern Asia, and Latin America. POPULATION: Liveborn infants from 15 population-based cohorts. METHODS: Subnational, population-based studies with high-quality birth outcome data were invited to join the Vulnerable Newborn Measurement Collaboration. All studies included birthweight, gestational age measured by ultrasound or last menstrual period, infant sex and neonatal survival. We defined adequate birthweight as 2500-3999 g (reference category), macrosomia as ≥4000 g, moderate low as 1500-2499 g and very low birthweight as <1500 g. We analysed fine strata classifications of preterm, term and post-term: ≥42+0 , 39+0 -41+6 (reference category), 37+0 -38+6 , 34+0 -36+6 ,34+0 -36+6 ,32+0 -33+6 , 30+0 -31+6 , 28+0 -29+6 and less than 28 weeks. MAIN OUTCOME MEASURES: Median and interquartile ranges by study for neonatal mortality rates (NMR) and relative risks (RR). We also performed meta-analysis for the relative mortality risks with 95% confidence intervals (CIs) by the fine categories, stratified by regional study setting (sub-Saharan Africa and Southern Asia) and study-level NMR (≤25 versus >25 neonatal deaths per 1000 live births). RESULTS: We found a dose-response relationship between lower gestational ages and birthweights with increasing neonatal mortality risks. The highest NMR and RR were among preterm babies born at <28 weeks (median NMR 359.2 per 1000 live births; RR 18.0, 95% CI 8.6-37.6) and very low birthweight (462.8 per 1000 live births; RR 43.4, 95% CI 29.5-63.9). We found no statistically significant neonatal mortality risk for macrosomia (RR 1.1, 95% CI 0.6-3.0) but a statistically significant risk for all preterm babies, post-term babies (RR 1.3, 95% CI 1.1-1.5) and babies born at 370 -386 weeks (RR 1.2, 95% CI 1.0-1.4). There were no statistically significant differences by region or underlying neonatal mortality. CONCLUSIONS: In addition to tracking vulnerable newborn types, monitoring finer categories of birthweight and gestational age will allow for better understanding of the predictors, interventions and health outcomes for vulnerable newborns. It is imperative that all newborns from live births and stillbirths have an accurate recorded weight and gestational age to track maternal and neonatal health and optimise prevention and care of vulnerable newborns.

Defining a Dichotomous Indicator for Population-Level Assessment of Dietary Diversity Among Pregnant Adolescent Girls and Women: A Secondary Analysis of Quantitative 24-h Recalls from Rural Settings in Bangladesh, Burkina Faso, India, and Nepal.

Background: The Minimum Dietary Diversity for Women of Reproductive Age (MDD-W) indicator was validated as a proxy of micronutrient adequacy among nonpregnant women in low- and middle-income countries (LMICs). At that time, indeed, there was insufficient data to validate the indicator among pregnant women, who face higher micronutrient requirements. Objective: This study aimed to validate a minimum food group consumption threshold, out of the 10 food groups used to construct MDD-W, to be used as a population-level indicator of higher micronutrient adequacy among pregnant women aged 15-49 y in LMICs. Methods: We used secondary quantitative 24-h recall data from 6 surveys in 4 LMICs (Bangladesh, Burkina Faso, India, and Nepal, total n = 4909). We computed the 10-food group Women's Dietary Diversity Score (WDDS-10) and calculated the mean probability of adequacy (MPA) of 11 micronutrients. Linear regression models were fitted to assess the associations between WDDS-10 and MPA. Sensitivity, specificity, and proportion of individuals correctly classified were used to assess the performance of MDD-W in predicting an MPA of >0.60. Results: In the pooled sample, median values (interquartile range) of WDDS-10 and MPA were 3 (1) and 0.20 (0.34), respectively, whereas the proportion of pregnant women with an MPA of >0.60 was 9.6%. The WDDS-10 was significantly positively associated with MPA in each survey. Although the acceptable food group consumption threshold varied between 4 and 6 food groups across surveys, the threshold of 5 showed the highest performance in the pooled sample with good sensitivity (62%), very good specificity (81%), and percentage of correctly classified individuals (79%). Conclusions: The WDDS-10 is a good predictor of dietary micronutrient adequacy among pregnant women aged 15-49 y in LMICs. Moreover, the threshold of 5 or more food groups for the MDD-W indicator may be extended to all women of reproductive age, regardless of their physiologic status.

Association between adherence to the EAT-Lancet sustainable reference diet and cardiovascular health among European adolescents: the HELENA study.

BACKGROUND: The EAT-Lancet Commission proposed a global reference diet to promote healthy diets within planetary boundaries. Studies evaluating the associations between the reference diet with health outcomes among adolescents are scarce. Thus, our aim was to assess the association between adherence to the EAT-Lancet diet and cardiovascular health among European adolescents. METHODS: Data from the HELENA study were used. Usual dietary intake was assessed using two 24-h dietary recalls and adherence to the EAT-Lancet diet was assessed using the Planetary Health Diet Index (PHDI), a 16-component index that ranges from 0 to 150 points. Cardiovascular health was assessed through the seven-component Ideal Cardiovascular Health (ICH) score: never smoked, eutrophic body mass index, moderate-to-vigorous physical activity, healthy dietary pattern, low blood pressure, low fasting plasma glucose, and low total cholesterol. Total ICH score was categorized into ideal (5-7) and non-ideal (0-4). RESULTS: A 10-point increment in the PHDI was associated with a lower probability of a non-ideal ICH status (OR 0.84, [95% CI: 0.75, 0.94]) among European adolescents, after adjusting for age, sex, socio-economic status, and total energy intake. Furthermore, a 10-point increment in the PHDI was associated with lower probability of high blood pressure (OR: 0.87 [0.79, 0.96]) and a lower probability of high blood cholesterol (OR: 0.88 [0.78, 0.99]). CONCLUSION: Our study suggests that a higher PHDI may be associated with a better cardiovascular health status among European adolescents.

Perspective: Peer Evaluation of Recommendations for CONSORT Guidelines for Randomized Controlled Trials in Nutrition.

Creating effective dietary guidance requires a rigorous evidence base that is predominantly developed from robust clinical trials or large-scale cohort studies, with the quality of the data available depending on the completeness and accuracy of their reporting. An international group of academics from 14 institutions in 12 different countries and on 5 continents, working on behalf of the Federation of European Nutrition Societies within its "Improving Standards in the Science of Nutrition" initiative, reviewed the Consolidated Standards of Reporting Trials (CONSORT) statement checklist as it pertains to nutrition trials. This perspective piece documents the procedure followed to gain input and consensus on the checklist previously published by this group, including its presentation and interrogation at the International Union of Nutritional Sciences International Congress of Nutrition 2022 (IUNS-ICN 22), inputs from a survey of journal editors, and its piloting on 8 nutrition trials of diverse designs. Overall, the initiative has been met with considerable enthusiasm. At IUNS-ICN 22, refinements to our proposal were elicited through a World Café method discussion with participating nutrition scientists. The contributing journal editors provided valuable insights, and the discussion led to the development of a potential tool specific to assess adherence to the proposed nutrition extension checklist. The piloting of the proposed checklist provided evidence from real-life studies that reporting of nutrition trials can be improved. This initiative aims to stimulate further discussion and development of a CONSORT-nutrition-specific extension.

A Multi-Omics and Human Biomonitoring Approach to Assessing the Effectiveness of Fortified Balanced Energy-Protein Supplementation on Maternal and Newborn Health in Burkina Faso: A Study Protocol.

Fortified balanced energy-protein (BEP) supplementation is a promising intervention for improving maternal health, birth outcomes and infant growth in low- and middle-income countries. This nested biospecimen sub-study aimed to evaluate the physiological effect of multi-micronutrient-fortified BEP supplementation on pregnant and lactating women and their infants. Pregnant women (15-40 years) received either fortified BEP and iron-folic acid (IFA) (intervention) or IFA only (control) throughout pregnancy. The same women were concurrently randomized to receive either a fortified BEP supplement during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention) or the postnatal standard of care, which comprised IFA alone for 6 weeks postpartum (i.e., control). Biological specimens were collected at different timepoints. Multi-omics profiles will be characterized to assess the mediating effect of BEP supplementation on the different trial arms and its effect on maternal health, as well as birth and infant growth outcomes. The mediating effect of the exposome in the relationship between BEP supplementation and maternal health, birth outcomes and infant growth were characterized via biomonitoring markers of air pollution, mycotoxins and environmental contaminants. The results will provide holistic insight into the granular physiological effects of prenatal and postnatal BEP supplementation.

Unhealthy food consumption among Ecuadorian children: A cross-sectional study in the context of the school food regulation / Consumo de alimentos poco saludables en niños ecuatorianos: estudio transversal en el contexto del reglamento de alimentación escolar

Introduction. The intake of energy-dense unhealthy food at school could influence the overall energy intake of children. Objective: To characterize the patterns of buying a snack at school and to analyze the association of these patterns with the source of the school snack (brought from home or bought at school) and screen time. Materials and methods: A cross-sectional study was conducted from October 2018 until May 2019 among school children (9 to 12-year-olds) from Cuenca-Ecuador. Intake of energy-dense unhealthy food groups, the source of the school snack, and screen time were assessed using questionnaires. Multiple correspondence analysis was used to identify intake patterns of unhealthy food groups, and logistic regression to assess the association between intake of energy-dense unhealthy food groups (FG) with the school snack source. Results: Among 1,028 children recruited 63%, 42%, 30% and 22% of the children reported consuming sweets/confiture, savory snacks, fast food, and pastry products, respectively, at least two days per week. Around 39% of the children were classified as "Frequent consumers of energy-dense unhealthy FG". Buying the snack at school was associated with a more frequent intake of sweets/confiture (OR=1.56, CI 95% =1.05-2.32) and fast food (OR=2.01, CI 95% =1.15-3.50) during the week, as well as with being classified in the "frequent consumer of energy-dense unhealthy FG" (OR=1.99, 95% CI=1.40-2.82). Conclusions: Ecuadorian children still consume prohibited unhealthy foods at school. These results reinforce the importance of evaluating, monitoring, and adapting strategies to promote a balanced diet(AU)

Introducción. La ingesta de alimentos poco saludables con alto contenido energético en la escuela podría influir en la ingesta energética total de los niños. Objetivo: Caracterizar los patrones de compra de snacks en el colegio y analizar la asociación de estos patrones con la procedencia del snack escolar (de la casa o comprada en el colegio) y el tiempo de pantalla. Materiales y métodos: Se realizó un estudio transversal (octubre 2018-mayo 2019) en escolares (9-12 años) Cuenca- Ecuador. La ingesta de grupos de alimentos (FG) no saludables altos en energía, la fuente del snack escolar y el tiempo de pantalla se evaluaron mediante cuestionarios. Se utilizó análisis de correspondencias múltiples para identificar patrones de ingesta de FG poco saludables y la regresión logística para evaluar asociación entre la ingesta FG no saludables con la fuente del snack escolar. Resultados: En 1.028 niños 63%, 42%, 30% y 22% declararon consumir dulces/golosinas, aperitivos salados, comida rápida y productos de pastelería, respectivamente, al menos dos/días/ semana. Un 39% fueron clasificados como "Consumidores frecuentes de FG poco saludables de alta densidad energética". La compra de los snacks en el colegio se asoció con una ingesta más frecuente de dulces/golosinas (OR=1,56; IC95%=1,05-2,32) y comida rápida (OR=2,01; IC95%=1,15-3,50) durante la semana y con la clasificación en el grupo" consumidores frecuentes de FG poco saludables de alta densidad energética" (OR=1,99; IC95%=1,40- 2,82). Conclusiones: Los niños ecuatorianos aún consumen alimentos no saludables prohibidos en la escuela. Estos resultados refuerzan la importancia de evaluar, monitorear y adaptar estrategias para promover una dieta balanceada(AU)

Can common dietary assessment methods be better designed to capture the nutritional contribution of neglected, forest, and wild foods to diets?

Food systems are the primary cause of biodiversity loss globally. Biodiversity and specifically, the role that wild, forest and neglected and underutilised species (NUS) foods might play in diet quality is gaining increased attention. The narrow focus on producing affordable staples for dietary energy has contributed to largely homogenous and unhealthy diets. To date, evidence to quantify the nutritional contribution of these biodiverse foods is limited. A scoping review was conducted to document the methods used to quantify the contribution of wild, forest and NUS foods. We found 37 relevant articles from 22 different countries, mainly from Africa (45%), the Americas (19%), and Asia (10%). There were 114 different classifications used for the foods, 73% of these were specifically related to wild or forest foods. Most dietary assessments were completed using a single day qualitative or quantitative 24 h open recall (n = 23), or a food frequency questionnaire (n = 12). There were 18 different diet related indicators used, mainly nutrient adequacy (n = 9) and dietary diversity scores (n = 9). Often, no specific nutritionally validated diet metric was used. There were 16 studies that presented results (semi) quantitatively to measure the contribution of wild, forest or NUS foods to dietary intakes. Of these, 38% were aggregated together with broader classifications of 'traditional' or 'local' foods, without definitions provided meaning it was not possible to determine if or to what extend wild, forest of NUS foods were included (or not). In almost all studies there was insufficient detail on the magnitude of the associations between wild, forest or NUS foods and dietary energy or nutrient intakes or the (qualitative) diet recall methodologies that were used inhibited the quantification of the contribution of these foods to diets. A set of six recommendations are put forward to strengthen the evidence on the contribution of wild, NUS, and forest foods to human diets.

Quality of vital event data for infant mortality estimation in prospective, population-based studies: an analysis of secondary data from Asia, Africa, and Latin America.

INTRODUCTION: Infant and neonatal mortality estimates are typically derived from retrospective birth histories collected through surveys in countries with unreliable civil registration and vital statistics systems. Yet such data are subject to biases, including under-reporting of deaths and age misreporting, which impact mortality estimates. Prospective population-based cohort studies are an underutilized data source for mortality estimation that may offer strengths that avoid biases. METHODS: We conducted a secondary analysis of data from the Child Health Epidemiology Reference Group, including 11 population-based pregnancy or birth cohort studies, to evaluate the appropriateness of vital event data for mortality estimation. Analyses were descriptive, summarizing study designs, populations, protocols, and internal checks to assess their impact on data quality. We calculated infant and neonatal morality rates and compared patterns with Demographic and Health Survey (DHS) data. RESULTS: Studies yielded 71,760 pregnant women and 85,095 live births. Specific field protocols, especially pregnancy enrollment, limited exclusion criteria, and frequent follow-up visits after delivery, led to higher birth outcome ascertainment and fewer missing deaths. Most studies had low follow-up loss in pregnancy and the first month with little evidence of date heaping. Among studies in Asia and Latin America, neonatal mortality rates (NMR) were similar to DHS, while several studies in Sub-Saharan Africa had lower NMRs than DHS. Infant mortality varied by study and region between sources. CONCLUSIONS: Prospective, population-based cohort studies following rigorous protocols can yield high-quality vital event data to improve characterization of detailed mortality patterns of infants in low- and middle-income countries, especially in the early neonatal period where mortality risk is highest and changes rapidly.

A generic theory of change-based framework with core indicators for monitoring the effectiveness of large-scale food fortification programs in low- and middle-income countries.

Large-scale food fortification (LSFF) programs are widely implemented in low- and middle-income countries (LMIC) to alleviate micronutrient deficiencies. However, these programs may not achieve the desired impact due to poor design or bottlenecks in program implementation. Monitoring and evaluation (M&E) frameworks and a set of agreed indicators can help to benchmark progress and to strengthen the evidence-base of effectiveness in a standardized way. We aimed to formulate recommendations towards core indicators for evaluating the effectiveness of LSFF programs with their associated metrics, methods, and tools (IMMT). For this, we used a multi-method iterative approach, including a mapping review of the literature, semi-structured interviews with international experts, compilation of a generic Theory of Change (ToC) framework for LSFF program delivery, and selection of IMMT for M&E of LSFF programs at key stages along the ToC delivery framework. Lastly, we conducted exploratory, qualitative interviews with key informants in Nigeria to explore experiences and perceptions related to the implementation of LSFF programs in Nigeria's context, and their opinion towards the proposed set of core IMMT. The literature search resulted in 14 published and 15 grey literature documents, from which we extracted a total of 41 indicators. Based on the available literature and interviews with international experts, we mapped a ToC delivery framework and selected nine core indicators at the output, outcome and impact level for M&E of the effectiveness of LSFF programs. Key informants in Nigeria revealed that the main bottlenecks for implementation of the proposed IMMT are related to the lack of technical capacity, equipment, laboratory infrastructure, and financial resources. In conclusion, we propose a set of nine core indicators for enabling comprehensive M&E of the effectiveness of LSFF programs in LMIC. This proposed set of core indicators can be used for further evaluation, harmonization and integration in national and international protocols for M&E of LSFF programs.

Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso.

BACKGROUND: Micronutrient-fortified balanced energy-protein (BEP) supplements are promising interventions to prevent intrauterine growth retardation in low- and middle-income countries. On the other hand, one concern with blanket prenatal supplementation programs using energy-dense supplements is that they could lead to more maternal and/or infant overweight. However, evidence is lacking on the potential effect of BEP on maternal and offspring body composition. This study evaluates the effects of micronutrient-fortified BEP supplementation during pregnancy on body composition of mothers and their newborns in rural Burkina Faso. METHODS AND FINDINGS: The MISAME-III study is an open label individually randomized controlled trial where pregnant women (n = 1,897) of gestational age <21 weeks received either a combination of micronutrient-fortified BEP and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control). The prenatal phase of the MISAME-III study was conducted between the first enrollment in October 2019 and the last delivery in August 2021. In a sub-study nested under the MISAME-III trial, we evaluated anthropometry and body composition in newborns who were born starting from 17 November 2020 (n: control = 368 and intervention = 352) and their mothers (n: control = 185 and intervention = 186). Primary study outcomes were newborn and maternal fat-free mass (FFMI) and fat-mass (FMI) indices. We used the deuterium dilution method to determine FFMI and FMI and %FFM and %FM of total body weight within 1 month postpartum. Our main analysis followed a modified intention-to-treat approach by analyzing all subjects with body composition data available. Univariable and multivariable linear regression models were fitted to compare the intervention and control arms, with adjusted models included baseline maternal age, height, arm fat index, hemoglobin concentration and primiparity, household size, wealth and food security indices, and newborn age (days). At study enrollment, the mean ± SD maternal age was 24.8 ± 6.13 years and body mass index (BMI) was 22.1 ± 3.02 kg/m2 with 7.05% of the mothers were underweight and 11.5% were overweight. Prenatal micronutrient-fortified BEP supplementation resulted in a significantly higher FFMI in mothers (MD (mean difference): 0.45; 95% CI (confidence interval): 0.05, 0.84; P = 0.026) and newborns (MD: 0.28; 95% CI: 0.06, 0.50; P = 0.012), whereas no statistically significant effects were found on FMI. The effect of micronutrient-fortified BEP on maternal FFMI was greater among mothers from food secure households and among those with a better nutritional status (BMI ≥21.0 kg/m2 or mid-upper arm circumference (MUAC) ≥23 cm). Key limitations of the study are the relatively high degree of missing data (approximately 18%), the lack of baseline maternal body composition values, and the lack of follow-up body composition measurements to evaluate any long-term effects. CONCLUSIONS: Micronutrient-fortified BEP supplementation during pregnancy can increase maternal and newborn FFMI, without significant effects on FMI. TRIAL REGISTRATION: ClinicalTrials.gov with identifier NCT03533712.

Correction: Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pmed.1004186.].

Neonatal mortality risk of vulnerable newborns: A descriptive analysis of subnational, population-based birth cohorts for 238 203 live births in low- and middle-income settings from 2000 to 2017.

OBJECTIVE: We aimed to understand the mortality risks of vulnerable newborns (defined as preterm and/or born weighing smaller or larger compared to a standard population), in low- and middle-income countries (LMICs). DESIGN: Descriptive multi-country, secondary analysis of individual-level study data of babies born since 2000. SETTING: Sixteen subnational, population-based studies from nine LMICs in sub-Saharan Africa, Southern and Eastern Asia, and Latin America. POPULATION: Live birth neonates. METHODS: We categorically defined five vulnerable newborn types based on size (large- or appropriate- or small-for-gestational age [LGA, AGA, SGA]), and term (T) and preterm (PT): T + LGA, T + SGA, PT + LGA, PT + AGA, and PT + SGA, with T + AGA (reference). A 10-type definition included low birthweight (LBW) and non-LBW, and a four-type definition collapsed AGA/LGA into one category. We performed imputation for missing birthweights in 13 of the studies. MAIN OUTCOME MEASURES: Median and interquartile ranges by study for the prevalence, mortality rates and relative mortality risks for the four, six and ten type classification. RESULTS: There were 238 203 live births with known neonatal status. Four of the six types had higher mortality risk: T + SGA (median relative risk [RR] 2.6, interquartile range [IQR] 2.0-2.9), PT + LGA (median RR 7.3, IQR 2.3-10.4), PT + AGA (median RR 6.0, IQR 4.4-13.2) and PT + SGA (median RR 10.4, IQR 8.6-13.9). T + SGA, PT + LGA and PT + AGA babies who were LBW, had higher risk compared with non-LBW babies. CONCLUSIONS: Small and/or preterm babies in LIMCs have a considerably increased mortality risk compared with babies born at term and larger. This classification system may advance the understanding of the social determinants and biomedical risk factors along with improved treatment that is critical for newborn health.

Relative validity of the Planetary Health Diet Index by comparison with usual nutrient intakes, plasma food consumption biomarkers, and adherence to the Mediterranean diet among European adolescents: the HELENA study.

PURPOSE: The EAT-Lancet Commission proposed an evidence-based global reference diet to improve human health within planetary boundaries. Recently, the Planetary Health Diet Index (PHDI) was developed based on the EAT-Lancet recommendations and validated among Brazilian adults. However, the relative validity of the PHDI in adolescents has yet to be assessed. Thus, we aimed to evaluate the relative validity of the PHDI in European adolescents. METHODS: We used cross-sectional data from 1804 adolescents (12.5-17.5 years) enrolled in the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) study. The PHDI (0-150 points) was calculated based on dietary intake data from two non-consecutive 24-h dietary recalls. Associations between the PHDI and usual nutrient intakes, plasma food consumption biomarkers, and adherence to the Mediterranean diet were evaluated using multivariable-adjusted mixed-effects linear regression models. RESULTS: Higher PHDI score was associated with greater intakes of nutrients predominantly from plant-source foods, such as vegetable protein, vitamin E, and folate and with lower intake of nutrients predominately from animal-source foods, such as total and saturated fat, cholesterol, and animal protein. Furthermore, a higher PHDI score was also positively associated with plasma ß-carotene, vitamin C, vitamin D, folate, and ferritin concentrations, while negatively associated with trans-fatty acids concentration. Moreover, higher PHDI was related to a greater adherence to the Mediterranean dietary pattern. CONCLUSIONS: The PHDI showed good relative validity among adolescents in the HELENA study. Hence, future research should assess adherence to the PHDI and long-term health outcomes.

Mycotoxins Exposure of Lactating Women and Its Relationship with Dietary and Pre/Post-Harvest Practices in Rural Ethiopia.

Mycotoxins can be transferred to breast milk during lactation. Hence, the presence of multiple mycotoxins (aflatoxins B1, B2, G1, G2, and M1, alpha and beta zearalanol, deoxynivalenol, fumonisins B1, B2, B3, and hydrolyzed B1, nivalenol, ochratoxin A, ochratoxin alpha, and zearalenone) in breast milk samples was assessed in our study. Furthermore, the relationship between total fumonisins and pre/post-harvest and the women's dietary practices was examined. Liquid chromatography coupled with tandem mass spectrometry was used to analyze the 16 mycotoxins. An adjusted censored regression model was fitted to identify predictors of mycotoxins, i.e., total fumonisins. We detected only fumonisin B2 (15% of the samples) and fumonisin B3 (9% of the samples) while fumonisin B1 and nivalenol were detected only in a single breast milk sample. No association between total fumonisins and pre/post-harvest and dietary practices was found (p < 0.05). The overall exposure to mycotoxins was low in the studied women, although fumonisins contamination was not negligible. Moreover, the recorded total fumonisins was not associated with any of the pre/post-harvest and dietary practices. Therefore, to better identify predictors of fumonisin contamination in breast milk, longitudinal studies with food samples in addition to breast milk samples and with larger sample sizes are needed for the future.

Perspectives on the application of CONSORT guidelines to randomised controlled trials in nutrition.

PURPOSE: Reporting guidelines facilitate quality and completeness in research reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement is widely applied to dietary and nutrition trials but has no extension specific to nutrition. Evidence suggests poor reporting in nutrition research. The Federation of European Nutrition Societies led an initiative to make recommendations for a nutrition extension to the CONSORT statement towards a more robust reporting of the evidence base. METHODS: An international working group was formed of nutrition researchers from 14 institutions in 12 different countries and on five continents. Using meetings over a period of one year, we interrogated the CONSORT statement specifically for its application to report nutrition trials. RESULTS: We provide a total of 28 new nutrition-specific recommendations or emphasised recommendations for the reporting of the introduction (three), methods (twelve), results (five) and discussion (eight). We also added two additional recommendations that were not allocated under the standard CONSORT headings. CONCLUSION: We identify a need to provide guidance in addition to CONSORT to improve the quality and consistency of the reporting and propose key considerations for further development of formal guidelines for the reporting of nutrition trials. Readers are encouraged to engage in this process, provide comments and conduct specific studies to inform further work on the development of reporting guidelines for nutrition trials.

Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies.

BACKGROUND: Journal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies' risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored. OBJECTIVE: We aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses. METHODS: Two independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a sample of diet- and nutrition-related RCTs; the second will include a sample of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap; Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework. RESULTS: The literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random samples of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023. CONCLUSIONS: Our meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43537.

Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

BACKGROUND: Optimal nutrition is crucial during the critical period of the first 1,000 days from conception to 2 years after birth. Prenatal and postnatal supplementation of mothers with multimicronutrient-fortified balanced energy-protein (BEP) supplements is a potential nutritional intervention. However, evidence on the long-term effects of BEP supplementation on child growth is inconsistent. We evaluated the efficacy of daily fortified BEP supplementation during pregnancy and lactation on infant growth in rural Burkina Faso. METHODS AND FINDINGS: A 2 × 2 factorial individually randomized controlled trial (MISAME-III) was implemented in 6 health center catchment areas in Houndé district under the Hauts-Bassins region. From October 2019 to December 2020, 1,897 pregnant women aged 15 to 40 years with gestational age <21 completed weeks were enrolled. Women were randomly assigned to the prenatal intervention arms receiving either fortified BEP supplements and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control), which is the standard of care during pregnancy. The same women were concurrently randomized to receive either of the postnatal intervention, which comprised fortified BEP supplementation during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention), or the postnatal control, which comprised IFA alone for 6 weeks postpartum (i.e., control). Supplements were provided by trained village-based project workers under direct observation during daily home visits. We previously reported the effect of prenatal BEP supplementation on birth outcomes. The primary postnatal study outcome was length-for-age z-score (LAZ) at 6 months of age. Secondary outcomes were anthropometric indices of growth (weight-for length and weight-for-age z-scores, and arm and head circumferences) and nutritional status (prevalence rates of stunting, wasting, underweight, anemia, and hemoglobin concentration) at 6 months. Additionally, the longitudinal prevalence of common childhood morbidities, incidence of wasting, number of months of exclusive breastfeeding, and trajectories of anthropometric indices from birth to 12 months were evaluated. Prenatal BEP supplementation resulted in a significantly higher LAZ (0.11 standard deviation (SD), 95% confidence interval (CI) [0.01 to 0.21], p = 0.032) and lower stunting prevalence (-3.18 percentage points (pp), 95% CI [-5.86 to -0.51], p = 0.020) at 6 months of age, whereas the postnatal BEP supplementation did not have statistically significant effects on LAZ or stunting at 6 months. On the other hand, postnatal BEP supplementation did modestly improve the rate of monthly LAZ increment during the first 12 months postpartum (0.01 z-score/month, 95% CI [0.00 to 0.02], p = 0.030), whereas no differences in growth trajectories were detected between the prenatal study arms. Furthermore, except for the trend towards a lower prevalence of underweight found for the prenatal BEP intervention at 6 months (-2.74 pp, 95% CI [-5.65 to 1.17], p = 0.065), no other secondary outcome was significantly affected by the pre- or postnatal BEP supplementation. CONCLUSIONS: This study provides evidence that the benefits obtained from prenatal BEP supplementation on size at birth are sustained during infancy in terms of linear growth. Maternal BEP supplementation during lactation may lead to a slightly better linear growth towards the second half of infancy. These findings suggest that BEP supplementation during pregnancy can contribute to the efforts to reduce the high burden of child growth faltering in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03533712.

Harmonization of maternal balanced energy-protein supplementation studies for individual participant data (IPD) meta-analyses - finding and creating similarities in variables and data collection.

BACKGROUND: Public health and clinical recommendations are established from systematic reviews and retrospective meta-analyses combining effect sizes, traditionally, from aggregate data and more recently, using individual participant data (IPD) of published studies. However, trials often have outcomes and other meta-data that are not defined and collected in a standardized way, making meta-analysis problematic. IPD meta-analysis can only partially fix the limitations of traditional, retrospective, aggregate meta-analysis; prospective meta-analysis further reduces the problems. METHODS: We developed an initiative including seven clinical intervention studies of balanced energy-protein (BEP) supplementation during pregnancy and/or lactation that are being conducted (or recently concluded) in Burkina Faso, Ethiopia, India, Nepal, and Pakistan to test the effect of BEP on infant and maternal outcomes. These studies were commissioned after an expert consultation that designed recommendations for a BEP product for use among pregnant and lactating women in low- and middle-income countries. The initiative goal is to harmonize variables across studies to facilitate IPD meta-analyses on closely aligned data, commonly called prospective meta-analysis. Our objective here is to describe the process of harmonizing variable definitions and prioritizing research questions. A two-day workshop of investigators, content experts, and advisors was held in February 2020 and harmonization activities continued thereafter. Efforts included a range of activities from examining protocols and data collection plans to discussing best practices within field constraints. Prior to harmonization, there were many similar outcomes and variables across studies, such as newborn anthropometry, gestational age, and stillbirth, however, definitions and protocols differed. As well, some measurements were being conducted in several but not all studies, such as food insecurity. Through the harmonization process, we came to consensus on important shared variables, particularly outcomes, added new measurements, and improved protocols across studies. DISCUSSION: We have fostered extensive communication between investigators from different studies, and importantly, created a large set of harmonized variable definitions within a prospective meta-analysis framework. We expect this initiative will improve reporting within each study in addition to providing opportunities for a series of IPD meta-analyses.

Health risk-benefit assessment of the commercial red mangrove crab: Implications for a cultural delicacy.

Mangrove forests, provide vital food resources and are an endangered ecosystem worldwide due to pollution and habitat destruction. A risk-benefit assessment (RBA) was performed on the red mangrove crab (Ucides occidentalis) from the threatened Guayas mangroves in Ecuador. It was aimed to assess the combined potential adverse and beneficial health impact associated with crab consumption and define a recommended safe intake (SI) to improve the diet of the Ecuadoran population while ensuring safe food intake. Target hazard quotients (THQs), benefit quotients (Qs), and benefit-risk quotients (BRQs) were calculated based on the concentrations of the analyzed contaminants (121 pesticide residues, 11 metal(loid)s, antimicrobial drugs from 3 classes) and nutrients (fatty acids, amino acids, and essential nutrients). Except for inorganic arsenic (iAs), the THQ was below 100 for all investigated contaminants, suggesting that the average crab consumer is exposed to levels that do not impose negative non-carcinogenic or carcinogenic health effects in the long and/or short term. Concentrations of iAs (average AsIII: 25.64 and AsV: 6.28 µg/kg fw) were of the highest concern because of the potential to cause negative health effects on long-term consumption. Despite the thriving aquaculture in the Guayas estuary, concentrations of residues of the antimicrobial drugs oxytetracycline (OTC), florfenicol, and nitrofurans still were low. Based on the fact that different risk reference values exist, related to different safety levels, four SI values (0.002, 0.04, 4, and 18 crabs/day) were obtained. The strictest intake values indicate a concern for current consumption habits. In conclusion, the red mangrove crab contains various important nutrients and can be part of a balanced diet for the Ecuadorian population when consumed in limited portions. The present study emphasizes the importance of safeguarding the quality of the environment as a prerequisite for procuring nutritious and safe food.